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Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment

Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…

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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…

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